Lenire — Bimodal Stimulation Treatment by Neuromod

This is what I wrote about what was to become Lenire in December 2018 (when it was still calling itself MuteButton Two):

December 2018:
"The folk on here drinking the Kool-aid don't want to hear about it and will shout down anyone with a degree of skepticism. Clearly a lot of the hype is being encouraged by the makers of MuteButton itself

Some short predictions on how this will play out:
1. MuteButton (2) is released to great fanfare.
2. Some desperate tinnitus sufferers spend a lot of money on it.
3. Most of them find it doesn't help at all, some people find it helps a little bit with habituation.
4. MuteButton is withdrawn from the market for "improvements".
5. A few years later MuteButton (3) is released.

In short this thread will make interesting reading in a couple of years time."​

I hate to say I told you so...

 

Have you read the user reviews thread? It seems like most people here haven't. When I did a cursory tally about half of the users endorsed their experience as positive.

 

To GBB:
This was my analysis on 05/28/20:

Tinnitus Since:
01/2014
Cause of Tinnitus:
Headcold/Flu

This study indicates how truly valuable Tinnitus Talk is. We would never have gotten this thoroughly researched, unbiased data through any other source. I intend to make an additional donation.

To summarize. If you undertake Lenire:
1) You have slightly more than a 2 out of 5 chance of a reduction;
2) You have slightly more than a 1 out of 3 chance of no change;
3) You have slightly more than a 1 out of 5 chance of getting worse (and in some instances being compelled to discontinue).

I am disappointed that there was no category indicating that it was eliminated completely.
Did Lenire ever warn prospective users that this 1 in 5 chance could occur? What concerns me is those who dropped out because of adverse outcomes. Does that mean that this worsening was permanent or long term?

I will be very curious about Lenire's response to all aspects of the report.

Do I want to spend in excess of $3,000.00 for a 2 out of 5 chance of improvement (and a 1 out of 5 chance of worsening?)

I am reminded of Clint Eastwood's classic remark, "Do you feel lucky? Well punk, do you?"

It takes all I have to maintain even a semblance of stability given my present condition.

Any worsening would be catastrophic with consequences that I prefer not to imagine.
Each of us will have to make our own carefully measured assessment before going forward with this.

 

As one of those positive cases, it is pretty important to remember that at least in my case (and in some others) it is a 'soft' positive.

 

I understand, but his question was has anyone (read: a single solitary person) had a good experience. It seems the answer would be a resounding yes.

 

Slightly more than 2/5 sounds like the 50% I mentioned, so I think we are on the same page.

I agree the prospect of worsening is something they have been disingenuous about, but if someone said to me I'll give you a pill that can make you worse, but the chance of improvement is 2:1, I would seriously consider those odds.

Frankly I don't mean to be an armchair spectator; if my condition allowed me to drive/fly I would have tried it already.

 

To GBB:

My current reservations regarding Lenire consists in the fact that their most recent posting states that there was "a 15% reduction in THI" (Tinnitus Handicap Index). This seems to be an utterly unsubstantiated, arbitrary, self-generated measure of improvement; they are actually hedging on the question of any real reductions in volume.

However, this is not yet available in the USA since it has not yet received FDA approval.

The last time I saw my ENT Doctor I mentioned that this device stimulated the Trigeminal Nerve, and he cautioned me very seriously about such activation; if you Google "Trigeminal Nerve Pain", you will find that it is also called "The Suicide Disease." He said that the intensity of this pain will make even the major discomfort of chronic tinnitus appear insignificant.

 

Will Neuromod improve their treatment parameters in time? In the videos they mentioned further clinical trials and changes in setting if I am not wrong.

 

I would be very interested in learning about the FDA's carefully considered assessment of whatever "Trial Data" Lenire submitted (and whether and when it will meet the required acceptable criteria for release in the US).

Is the FDA being extra cautious because of all of the previous tinnitus devices they approved (such as Desyncra and other Neuromodulation treatments) that turned out to be no more effective that shining a flashlight on your head would have been?

 

I am not optimistic that they will. Now there were definite limitations for how I interacted with Neuromod due the pandemic (I got mine right before everything shut down), but they really didn't collect any data from me, on how I was doing or anything else. Again maybe this would have been different if I had been able to visit their offices again instead of just doing phone conversations.

 

I'm just having a very good run with Lenire. What have I done?

- my girlfriend left me after 4.5 years
- went down to 30 minute a day (1 session)
- 2000 IE Vitamin D / day
- 4000 mg Omega 3 FA / day
- more running
- quit vaping weed (there is more and more evidence that weed might even cause tinnitus )

My appointment for a program change is in 2 weeks after more than 1 year with PS1.

Wish me luck guys.
Cheers.

 

Hello Mr. Sir on Ketchup.

What did you mean by "very good run" and what do you feel/if you can a little elaborate what's the difference compared to your previous runs (I assume that you had at least one round with Lenire in the past)?

Simply said - I am interested in more details about your current run, what week you're in and how does your tinnitus behave during/after the session and if there is any noticeable change, also in the context of previous runs?

Is Neuromod still interested in your progress after 1 year or do they not care anymore? Have you initiated the change of program from PS1 or did they offer such change?

Will the change be done remotely? Device connected to PC or laptop, remote session and remote desktop or do they have some interface/app or software to download and apply such update?

Thanks and good luck!

 

Me.

 

@RODRIGO, did Lenire help you?

 

Dorsal column it is!

 

That was what happened with Mutebutton. This was supposed to be different (tm).

 

I emailed Neuromod today. They told me the TENT-A1 trial results are in a peer reviewed scientific journal.

Has the peer review been available all along?

 

Yes, Lenire helped me.

 

@RODRIGO, what level of efficacy have you felt? 50% or more? Did you have ringing only in the ears, or in the head too? Thanks for the information!

 

I would never consider Lenire. I don't trust Neuromod. Period. But if someone is helped by their device I am happy for them.

 

I'm going insane. After I stopped using Lenire in November, I ended up with having 4-5 good days, then 2-3 bad days. It was a cycle. It was predictable. It worked because I was able to relax, calm my nerves, get some sleep and prepare mentally for the bad days.

After I started the keto diet, my tinnitus has been dreadful for 2 weeks straight. I'm in full blown panic and don't know what to do.

I just called the office in Ireland again and they're calling me back later today. I have an appointment with a chiropractor in 1 hour. If that doesn't help, I'm seriously considering starting to use Lenire again. I don't have any other options. I need to go back to the cycle, so I can function. I'm extremely on edge now and I feel like I'm about to have a mental breakdown. It hasn't been this bad since 2019.

 

Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study

 

It was published but I think the lack of a control group made the study seem pretty blah (technical term).

 

After looking into the mechanism of Lenire, I suspect it's like this:

They're trying to make your tinnitus become like your nose in your peripheral vision. In the words of Hubert Lim: "The brain only has so much bandwidth for attention".

Well, I suspect that this method works for those with a small nose, where size of the nose is a metaphor for severity of tinnitus.

 

What you're describing is habituation. That's not my reading of their original claims, although Lim's rhetoric of late definitely suggests it.

My reading of their claims was that they were literally brain-hacking in order to stop the errant signals from firing in the first place. It's a biofeedback device not unlike things that are being done to alleviate Parkinson's or epilepsy, just in a less invasive way.

 

This is a distraction device. It's getting your brain to deprioritize the tinnitus. I can't find the source, but Hubert Lim has stated it becomes "like the shirt on your back", it just gets shifted out of your awareness, which has limited bandwidth.

 

If that's the case then it's a clear marketing pivot. This was originally advertised as a one-and-done treatment to reduce tinnitus. You're free to read back in the thread to verify that I'm not making this up. They seem to be counting on people coming into this not having known any different and having lower expectations.

 

Where did you have your PRP done? I might go to India or Korea to give it try.

 

I have to try it for myself, but I could see it actually fulfilling both - the way I've heard it described it stimulates the whole brain or area of the brain where tinnitus manifests, making it so "every cell", not just the tinnitus cluster, is firing. The question for me is, could the emergent property of this experience at a consciousness level result in less perception of tinnitus, sort of like sitting on one pin, versus a bed of pins? We've certainly had people claim it makes tinnitus both better and worse. If it comes to the US I'll be one of the first ones to try.

I will say it is super weird to me that if it works I can find literally no reviews outside of the scant few on this site - Google returns NOTHING. Where are all these people whose tinnitus has been soothed? Are they entirely techno-illiterate?

 

Authors of Bimodal Stimulation encoded the truth about it into its name. Yes, it's BS!